Atopic Dermatitis Itch

Condition(s) targeted: Cutaneous Nerves CNS Itch

Intervention: Clonidine (Drug); Naltrexone (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Maria Hordinsky, MD, Study Chair, Affiliation: University of Minnesota - Clinical and Translational Science Institute

The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone in subjects with symptomatic atopic dermatitis.

Official title: Treatment of Chronic Itch in Atopic Dermatitis With Oral Clonidine and Oral Naltrexone

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction in Itch

Detailed description: This study will serve as a pilot study to determine the efficacy and safety of two novel oral agents (clonidine, naltrexone) in the treatment of chronic, non-experimentally induced itch in atopic dermatitis. In this study, eight subjects with symptomatic atopic dermatitis will be recruited and treated with either oral clonidine (four subjects) or oral naltrexone (four subjects) . Disease burden will be evaluated before and after 4 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, and clinical assessment.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age range 18-40 years old and ability to give informed consent and HIPAA authorization. 2. Female subjects of childbearing potential must have a negative pregnancy test, and must agree to practice two methods of effective birth control during the study period as clonidine is an FDA pregnancy category C drug (including abstinence, oral or implant contraceptives or condoms). 3. Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of 2 or greater 4. Willingness to adhere to study protocol Exclusion Criteria: 1. Use of topical anti-inflammatory medications for 2 weeks or oral anti-inflammatory medications 4 weeks prior to the study start 2. Use of chronic pain medications (including opioids, antidepressants and antiepileptic drugs) 3. History of radiation or chemotherapy 4. History of traumatic injury on perspective test sites 5. Use of hormone-replacement medication within six weeks prior to the study start to avoid any confounding influence on sensory and pain perception (Fillingim & Edwards, 2001). 6. Unstable thyroid function to exclude thyroid related neuropathy (Duyff et al, 2000) 7. Known history of central or peripheral nervous system dysfunction 8. History of acute hepatitis, chronic liver disease or end stage liver disease 9. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome 10. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or(polychlorinated biphenyls) 11. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start 12. Illicit drug use 13. History of daily use of power tools 14. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents

University of Minnesota Department of Dermatology, Minneapolis, Minnesota 55414, United States; Recruiting
Erin Dodd, Phone: 612-624-5721, Email: derm@umn.edu
Maria Hordinsky, MD, Principal Investigator
George Wilcox, PhD, Sub-Investigator
Elizabeth Hurliman, MD, Sub-Investigator

Starting date: July 2015
Last updated: August 11, 2015